NDA Granted Priority Review for Stivarga for GI Stromal Tumors

Bayer HealthCare and Onyx announced today that the FDA granted priority review to the New Drug Application (NDA) filed at the end of August 2012 for Stivarga (regorafenib) tablets to treat patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with two kinase inhibitors. The submission was based upon data from the global Phase 3 GRID study.

This priority review follows the recent FDA approval of Stivarga for the treatment of patients with metastatic colorectal cancer (mCRC) who had been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.

Regorafenib is an investigational oral multi-kinase inhibitor currently being studied in clinical trials for its potential to treat patients with various tumor types.

For more information visit www.onyx.com or www.bayer.com.